Time the pharma industry popped the quality pill

PT Jyothi Datta | Updated on January 13, 2018 Published on March 04, 2017


Drug regulators outline the perils of the absence of a culture of compliance

The cost of bad quality can have a devastating impact on a company, beyond financial liability. In the context of medicines that impact is on patients.

Though this may seem like an obvious observation, it formed the central theme of a recent pharma industry conclave, reiterating the need for a quality-oriented culture in drug companies.

With representation of drug regulators from India, the US, the UK and France, the conclave came at a time when some of the industry's top drugmakers are facing regulatory action in foreign markets or are in the process of remediation efforts. Naturally, the message going out from the conclave was unambiguous.

There is no place for short-cuts. Companies need to get their operations right the first time, have early-warning systems to pick up quality or data transgressions, and they need to identify the root cause and take remedial actions to fix the problem.

After all, those who fail to learn from history are doomed to repeat it, said Gerald W Heddell of the UK's MHRA (Medicines and Healthcare products Regulatory Agency), quoting Winston Churchill. In a sense, there is nothing really new about the “quality culture”, he said, referring to an incident in 1972 in the UK linking contaminated infusion fluids to the deaths of five people.

An inquiry committee under CM Clothier, in its principal conclusions, said “....no imminent technological advance in the field of production of intravenous fluids which will eliminate the need for skillful men devoted to their work.” After 45 years, these observations are still relevant, said Heddell, stressing the need for committed leadership, skilled employees and constant vigilance.

Nailing jelly

Measuring quality culture may be like nailing jelly to the wall. Nevertheless, what the UK regulator is looking for is confidence that the company is, and will remain, in control; has an understanding of how quality impacts the patient; confidence in quality related decision making and a mature mindset, he said. For instance, compliance at an employee level should be not just because it needs to be done, but with an understanding that it was important to the end consumer, the patient in this case.

Repeating a quote from another company chief, he said, companies need to reward staff for speaking up and giving them the bad news to catch a transgression before it flares up into action against them by a regulator.

Driving home a similar point, Mathew T Thomas, the US Food and Drug Administration's India office director said that “SOPs” (Standard operating procedure guidelines) need to get off the shelf and implemented on the ground.

In India, there are big and small drugmakers and it was important to bring all together to achieve the quality goal, he said, adding that India's technology expertise needed to be tapped to track and trace products etc.

The experience was not very different for France's regulatory authority, the EDQM. Pointing out that quality was a key villain in cases of non-compliance found during GMP (Good Manufacturing Practices) inspections, EDQM's Florence Benoit-Guyod urged drug companies making the finished medicine and the active pharmaceutical ingredient (API) to remain committed to quality.

Outlining data integrity non-compliances, the European Medicines Agency's Brendan Cuddy pointed to incidents where robust electronic and laboratory systems were absent, leading to data traceability and security problems.

In fact, data reliability guidelines for the industry were unveiled by Mckinsey & Co, which has been working with members of the Indian Pharmaceutical Alliance (a platform for large domestic drugmakers), organisers of this industry conclave.

In its second year, the conclave continued to see top industry representation and the audience received insights from multiple regulators on what companies need to look for and whether they were looking for it in the right place.

But a company official in the gathering pointed to a missing link. Drug regulators too need to listen to the woes of drug companies, the concerns they have with the regulatory systems, he said.

And this needs to be done through an interaction where questions are asked anonymously, so regulators get truthful feedback and companies don't get targeted, he added. Insightful feedback the IPA may want to address in its next regulator-industry interaction.

Published on March 04, 2017
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